Dental CariesNCT07902323
Effect of Xylitol- Versus Erythritol-Sweetened Mints on Plaque ATP-Bioluminescence Readings
A study testing Xylitol and Erythritol in people with Dental Caries and Dental Plaque, run by Loma Linda University.
Trial summary
This study will assess the effectiveness of erythritol and xylitol in suppressing biofilm activity, using both within-subject and between-group comparisons. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Caries, Dental Plaque
- What is being tested?
- Xylitol and Erythritol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2026to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects are 18 years or older;
- Subjects who will comply with study protocol;
- Subjects who can read and understand the consent form;
- Subjects available during the study period;
- Subjects have 20 or more natural teeth.
Who cannot join
- Allergy or intolerance to study product ingredients;
- Systemic antibiotic use within the preceding 30 days;
- Active oral infections;
- History of systemic diseases.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Xylitol- Versus Erythritol-Sweetened Mints on Plaque Adenosine Triphosphate (ATP)-Bioluminescence Readings: A Randomized Controlled Trial
This study will assess the effectiveness of erythritol and xylitol in suppressing biofilm activity, using both within-subject and between-group comparisons.
Read the detailed description
Xylitol and erythritol are sugar alcohols that cariogenic bacteria cannot readily ferment. Most clinical evidence comes from chewing gum; few studies have tested polyol mints in people, and none has compared xylitol and erythritol mints with a real-time measure of plaque activity.
This is a single-center, randomized (1:1), parallel-group, examiner-blinded trial in 80 healthy adults at Loma Linda University School of Dentistry. The randomization sequence is generated in jamovi. The xylitol group takes two Epic Xylitol mints (about 0.25 g xylitol each) twice daily; the erythritol group takes one DC24 Daily Care erythritol mint (about 0.5 g erythritol) twice daily. Both groups receive about 1 g of polyol per day for 7 days.
Participants arrive in the morning without brushing or eating. A trained, calibrated examiner who does not know the group assignment swabs the lingual surfaces of the lower anterior teeth for about 5 seconds, and the CariScreen meter reports a reading from 0 to 9,999 within about 15 seconds. A different, unblinded team member handles randomization and dispenses the mints. Measurements are taken at Visit 1 (baseline) and Visit 2 (after one week). Participants avoid other sugar-alcohol products during the study week. Adverse events are reviewed at Visit 2.
- Conditions
- Dental Caries, Dental Plaque
- Being tested
- Xylitol, Erythritol
- Keywords
- Biofilm, Sugar, xylitol, erythritol
- Medical subject headings
- Dental Caries, Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XylitolDietary supplement
Participants will consume two Epic Xylitol mints (~0.25 g xylitol each) twice daily for one week
ErythritolDietary supplement
Participants will consume one DC24 erythritol mint (~0.5 g erythritol) twice daily for one week
| Study group | Role | What they receive |
|---|---|---|
| Xylitol | Active comparator | Two Epic Xylitol mints (about 0.25 g xylitol each) dissolved in the mouth twice daily for one week, about 1 g xylitol per day. Receives: Dietary Supplement: Xylitol |
| Erythritol | Active comparator | One DC24 Daily Care erythritol mint (about 0.5 g erythritol) dissolved in the mouth twice daily for one week, about 1 g erythritol per day. Receives: Dietary Supplement: Erythritol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biofilm Metabolic Activity Assessment with Xylitol
Plaque from the lingual surfaces of the lower anterior teeth is swabbed and read immediately with the CariScreen ATP meter (relative light units, 0-9,999; higher = more bacterial metabolic activity). Change = 1 week post-baseline minus baseline, reported within each arm.
Measured: Change in biofilm activity between Visit 1 (baseline) and Visit 2 (1 week post-baseline)
Biofilm Metabolic Activity Assessment with Erythritol
Plaque from the lingual surfaces of the lower anterior teeth is swabbed and read immediately with the CariScreen ATP meter (relative light units, 0-9,999; higher = more bacterial metabolic activity). Change = 1 week post-baseline minus baseline, reported within each arm.
Measured: Change in biofilm activity between Visit 1 (baseline) and Visit 2 (1 week post-baseline)
Secondary outcomes (1)
Change in ATP reading by baseline caries risk category
Change from baseline in CariScreen reading, by American Dental Association (ADA) Caries Risk Assessment category (low, moderate, high).
Measured: Change in biofilm activity between Visit 1 (baseline) and Visit 2 (1 week post-baseline) by risk category (low, moderate, high)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study start1 Dec 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomized 1:1 to xylitol mints or erythritol mints for one week.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, So Ran Kwon, Loma Linda University
- Investigators
- So Ran Kwon, DDS, MS, PhD, Principal investigator, Loma Linda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07902323
- Sponsor's protocol ID
- SRK1234
- Status last verified
- Oct 2026
- First submitted
- 21 Oct 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Burt BA. The use of sorbitol- and xylitol-sweetened chewing gum in caries control. J Am Dent Assoc. 2006 Feb;137(2):190-6. doi: 10.14219/jada.archive.2006.0144.
PubMed 16521385Soderling E, Pienihakkinen K. Effects of xylitol and erythritol consumption on mutans streptococci and the oral microbiota: a systematic review. Acta Odontol Scand. 2020 Nov;78(8):599-608. doi: 10.1080/00016357.2020.1788721. Epub 2020 Jul 7.
PubMed 32633595Salli KM, Gursoy UK, Soderling EM, Ouwehand AC. Effects of Xylitol and Sucrose Mint Products on Streptococcus mutans Colonization in a Dental Simulator Model. Curr Microbiol. 2017 Oct;74(10):1153-1159. doi: 10.1007/s00284-017-1299-6. Epub 2017 Jul 17.
PubMed 28717846Rechmann P, Chaffee BW, Rechmann BMT, Featherstone JDB. Efficacy of an adenosine triphosphate meter for evaluating caries risk in clinical dental practice. J Am Dent Assoc. 2019 Oct;150(10):873-882. doi: 10.1016/j.adaj.2019.05.025. Epub 2019 Aug 28.
PubMed 31472759Martins ML, Monteiro ASN, Vieira TI, Guimaraes MBCT, de Abreu LCL, Cabral LM, Cavalcanti YW, Maia LC, Fonseca-Goncalves A. Effect of xylitol tablets with and without red propolis on salivary parameters, dental biofilm and sensory acceptability of adolescents: a randomized crossover clinical trial. Biofouling. 2020 Nov;36(10):1182-1195. doi: 10.1080/08927014.2020.1858063. Epub 2020 Dec 17.
PubMed 33334195
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Xylitol- Versus Erythritol-Sweetened Mints on Plaque Adenosine Triphosphate (ATP)-Bioluminescence Readings: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07902323
- Acronym / sponsor ID
- SRK1234
- Conditions
- Dental Caries, Dental Plaque
- Keywords
- Biofilm, Sugar, xylitol, erythritol
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 28 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will assess the effectiveness of erythritol and xylitol in suppressing biofilm activity, using both within-subject and between-group comparisons.
Detailed description
Xylitol and erythritol are sugar alcohols that cariogenic bacteria cannot readily ferment. Most clinical evidence comes from chewing gum; few studies have tested polyol mints in people, and none has compared xylitol and erythritol mints with a real-time measure of plaque activity.
This is a single-center, randomized (1:1), parallel-group, examiner-blinded trial in 80 healthy adults at Loma Linda University School of Dentistry. The randomization sequence is generated in jamovi. The xylitol group takes two Epic Xylitol mints (about 0.25 g xylitol each) twice daily; the erythritol group takes one DC24 Daily Care erythritol mint (about 0.5 g erythritol) twice daily. Both groups receive about 1 g of polyol per day for 7 days.
Participants arrive in the morning without brushing or eating. A trained, calibrated examiner who does not know the group assignment swabs the lingual surfaces of the lower anterior teeth for about 5 seconds, and the CariScreen meter reports a reading from 0 to 9,999 within about 15 seconds. A different, unblinded team member handles randomization and dispenses the mints. Measurements are taken at Visit 1 (baseline) and Visit 2 (after one week). Participants avoid other sugar-alcohol products during the study week. Adverse events are reviewed at Visit 2.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomized 1:1 to xylitol mints or erythritol mints for one week.
| Arm | Type | Receives |
|---|---|---|
| Xylitol | Active comparator | Dietary Supplement: XylitolTwo Epic Xylitol mints (about 0.25 g xylitol each) dissolved in the mouth twice daily for one week, about 1 g xylitol per day. |
| Erythritol | Active comparator | Dietary Supplement: ErythritolOne DC24 Daily Care erythritol mint (about 0.5 g erythritol) dissolved in the mouth twice daily for one week, about 1 g erythritol per day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects are 18 years or older;
- Subjects who will comply with study protocol;
- Subjects who can read and understand the consent form;
- Subjects available during the study period;
- Subjects have 20 or more natural teeth.
Key exclusion criteria (4 listed)
- Allergy or intolerance to study product ingredients;
- Systemic antibiotic use within the preceding 30 days;
- Active oral infections;
- History of systemic diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XylitolParticipants will consume two Epic Xylitol mints (~0.25 g xylitol each) twice daily for one week | Dietary supplement | Xylitol |
| ErythritolParticipants will consume one DC24 erythritol mint (~0.5 g erythritol) twice daily for one week | Dietary supplement | Erythritol |
Primary outcome
Biofilm Metabolic Activity Assessment with Xylitol
Time frame: Change in biofilm activity between Visit 1 (baseline) and Visit 2 (1 week post-baseline)
Plaque from the lingual surfaces of the lower anterior teeth is swabbed and read immediately with the CariScreen ATP meter (relative light units, 0-9,999; higher = more bacterial metabolic activity). Change = 1 week post-baseline minus baseline, reported within each arm.
Biofilm Metabolic Activity Assessment with Erythritol
Time frame: Change in biofilm activity between Visit 1 (baseline) and Visit 2 (1 week post-baseline)
Plaque from the lingual surfaces of the lower anterior teeth is swabbed and read immediately with the CariScreen ATP meter (relative light units, 0-9,999; higher = more bacterial metabolic activity). Change = 1 week post-baseline minus baseline, reported within each arm.
1 secondary outcome
Change in ATP reading by baseline caries risk category
Time frame: Change in biofilm activity between Visit 1 (baseline) and Visit 2 (1 week post-baseline) by risk category (low, moderate, high)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Background: PubMed 16521385Burt BA. The use of sorbitol- and xylitol-sweetened chewing gum in caries control. J Am Dent Assoc. 2006 Feb;137(2):190-6. doi: 10.14219/jada.archive.2006.0144.
- Background: PubMed 32633595Soderling E, Pienihakkinen K. Effects of xylitol and erythritol consumption on mutans streptococci and the oral microbiota: a systematic review. Acta Odontol Scand. 2020 Nov;78(8):599-608. doi: 10.1080/00016357.2020.1788721. Epub 2020 Jul 7.
- Background: PubMed 28717846Salli KM, Gursoy UK, Soderling EM, Ouwehand AC. Effects of Xylitol and Sucrose Mint Products on Streptococcus mutans Colonization in a Dental Simulator Model. Curr Microbiol. 2017 Oct;74(10):1153-1159. doi: 10.1007/s00284-017-1299-6. Epub 2017 Jul 17.
- Background: PubMed 31472759Rechmann P, Chaffee BW, Rechmann BMT, Featherstone JDB. Efficacy of an adenosine triphosphate meter for evaluating caries risk in clinical dental practice. J Am Dent Assoc. 2019 Oct;150(10):873-882. doi: 10.1016/j.adaj.2019.05.025. Epub 2019 Aug 28.
- Background: PubMed 33334195Martins ML, Monteiro ASN, Vieira TI, Guimaraes MBCT, de Abreu LCL, Cabral LM, Cavalcanti YW, Maia LC, Fonseca-Goncalves A. Effect of xylitol tablets with and without red propolis on salivary parameters, dental biofilm and sensory acceptability of adolescents: a randomized crossover clinical trial. Biofouling. 2020 Nov;36(10):1182-1195. doi: 10.1080/08927014.2020.1858063. Epub 2020 Dec 17.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
So Ran Kwon, DDS, MS, PhD principal investigator
Loma Linda University
Questions about this trial
What is this clinical trial studying?
A study testing Xylitol and Erythritol in people with Dental Caries and Dental Plaque, run by Loma Linda University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact So Ran Kwon, DDS, MS, PhD (909-558-4621, sorankwon@llu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biofilm Metabolic Activity Assessment with Xylitol (time frame: Change in biofilm activity between Visit 1 (baseline) and Visit 2 (1 week post-baseline)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07902323, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.